Clinical laboratory evaluation of a urine screening device.

A study was conducted to compare the Bac-T-Screen Bacterial Detection Device for Urines (BDD; Marion Laboratories, Kansas City, Mo.) with urine Gram stain as a screen for bacteriuria. We analyzed 631 urine samples with the BDD and compared the results to urine Gram stains and quantitative cultures. A total of 90 (14%) specimens could not be analyzed with the BDD due to interfering pigments (67 specimens) or clogging of the filter (23 specimens). Of the 541 specimens that were analyzed, the BDD correctly identified 67 (88.2%) of the 76 specimens with greater than or equal to 10(5) CFU/ml but only 294 (63.2%) of the 465 specimens with less than 10(5) CFU/ml. The majority of the false negative specimens had either gram-positive organisms or yeasts. The predictive value of a negative BDD reading was 97.0%. The urine Gram stain correctly identified 92.1% of all positive cultures and 77.8% of all negative cultures. The predictive value of a negative urine Gram stain was 98.4%. In summary, the BDD compares favorably with the urine Gram stain as a screen for bacteriologically negative urine specimens.